massimaux | 21 points
Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection (Bangladesh 2020-10-09): Results From First Double-Blind Placebo-Controlled IVM+DOXY RCT!Overall, positive results for Ivermectin + Doxycyclin!
Official Title: A Phase III Trial to Promote Recovery From Covid 19 With Combined Doxycycline and Ivermectin Along Standard Care
Study Start: June 1, 2020
Primary Completion: August 22, 2020 [Actual]
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 400 [Actual]
Arm 1:
Ivermectin 6 mg, 2 tab stat and Doxycycline 100 mg twice daily for 5 days
Drug: Standard of care
Paracetamol, Vitamin D, Oxygen if indicated, Low molecular weight heparin, dexamethasone if indicated
Arm 2:
Drug: Standard of care
Paracetamol, Vitamin D, Oxygen if indicated, Low molecular weight heparin, dexamethasone if indicated
1. Primary Outcome:
Measure Title: Number of Patients With Early Clinical Improvement
Time Frame: 7 days
Ivermectin Plus Doxycycline: 111/183 (60.7%)
Placebo: 80/180 (44.4%)
P-Value < 0.03
2. Primary Outcome:
Title: Number of Participants With Late Clinical Recovery
Description: Number of the patients required more than 12 days for clinical improvement as defined above.
Time Frame: 12 days
Ivermectin Plus Doxycycline: 42/183 (23.0%)
Placebo: 67/180 (37.2%)
P-Value < 0.004
3. Secondary Outcome
Title: Number of Patients Having Clinical Deterioration
Time Frame: 1 month
Ivermectin Plus Doxycycline: 16/183 (8.7%)
Placebo: 32/180 (17.8%)
P-Value < 0.013
4. Secondary Outcome
Title: Number of Patients Remain Persistently Positive for RT-PCR of Covid-19
Description: Number of Patients remain positive for RT-PCR of Covid-19 at day 14 after the day of initial positivity.
Time Frame: 14 days
Ivermectin Plus Doxycycline: 14/183 (7.7%)
Placebo: 36/180 (20.0%)
P-Value < 0.001
5. All-Cause Mortality (Time Frame: 1 month)
Ivermectin Plus Doxycycline: 0/183 (0%)
Placebo: 3/180 (1.67%)
6. Serious Adverse Events (Time Frame: 1 month)
Ivermectin Plus Doxycycline: 2/183 (1.09%) (Gastrointestinal disorders - Erosive esophagitis)
Placebo: 0/180 (0%)
7. Other (Not Including Serious) Adverse Events
Ivermectin Plus Doxycycline: 7/183 (3.83%) (Gastrointestinal disorders - Non ulcer Dyspepsia)
Placebo: 0/180 (0%)
[-] TrumpLyftAlles | 1 points
Excellent write-up!
Good strong results!
I'm having a hard time understanding the exact dosage, but if I'm reading correctly it was 12mg Ivermectin given once, so a lowish dose.
Also, this seems to target both hospitalised and outpatients, but doesn't seem to have details how it worked for hospitalised and outpatients separately.
[-] Haitchpeasauce | 3 points
Wow very fast posting! Positive results. Doxycycline dosage was 1 cap BD for 5 days, and I'm wondering whether it plays an important role in the patient outcome. Study mentions higher efficacy possible with a second dose of Ivermectin.
Limitations and Caveats
We followed up the patients by telephonic (video) interview, which has some inherent drawback for the study. we could not assess viral clearance directly. Only single dose regimen was used. Efficacy might higher if the different regimen would use.
[-] Ill-Hand-404 | 2 points
I know they have to have a placebo group for the study, but I feel bad for the people who died, when all they needed was 1 dose of ivermectin to improve their chances. how many more studies are needed before it becomes unethical. I am already convinced it works.
[-] TrumpLyftAlles | 2 points
Excellent post!
[-] Haitchpeasauce | 2 points
TrialSiteNews.com has posted a write up of the study. While it doesn't share any new information, it's presented in a way that is easy to understand, and expands the audience. Looking forward to seeing a paper.
https://www.trialsitenews.com/dhaka-medical-college-shares-results-of-randomized-controlled-trial-ivermectin-doxycycline-benefits-patients-with-mild-to-moderate-covid-19/
[-] LinkifyBot | 1 points
I found links in your comment that were not hyperlinked:
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[-] Ok-Film-9049 | 1 points
I looked at a study that said IVM can induce bleeding with warferin, a blood thinner. In this study the standard of care includes heparin. Maybe the extra blood thinning (via IVM) is preventing extensive micro thrombin and the cascade.
On a related note I will post a link below. It is basically saying 'start lots of treatment early at home'. Don't wait till you end up in hospital with lots of disease progression. At least for the over 50s.
https://www.google.com/amp/s/thehill.com/opinion/healthcare/518589-why-home-treatment-of-covid-19-with-several-drugs-is-crucial%3famp
BTW really encouraging to see the results of the trial!
[-] TrumpLyftAlles | 1 points
TrialSiteNews take on this study.
Primary outcome measures for this randomized controlled trial included 1) number of patients with early clinical improvement [that is, the number of patients that evidence clinical improvement as described by WHO and Bangladesh local guidelines] within 7 days; and 2) Number of participants with lengthy recovery—that is more than 12 days for clinical improvements.
The study team found for the primary outcome measure of Number of Patients with Early Clinical Improvement that 111 out of 180 (60.7%) in the active study drug group achieved that milestone while 80 out 180 (44.4%) in the placebo group wound up in this category.
What about Number of Participants with Late Clinical Recovery? The results reveal that those patients in the placebo group fared worse than those patients in the Ivermectin/doxycycline group. For example, 42 out of 183 (23%) of the patients in the active study drug group experienced a late recovery—e.g. required over 12 days to experience better conditions (e.g. body temperature, respiratory symptom improvement, etc.). However, in the placebo group 67 out of 180 (37.2%) took over 12 days to improve.
Seems like a modest win for ivermectin!?
single day is ridiculous, why even bother
even remdesivir is given over 5 days and that's a targeted anti-viral
they are basically trying to cure people with doxy in this study which won't work
the only ridiculous thing here is your comment.
[-] TrumpLyftAlles | 1 points
Let's keep it friendly, please.
thaw4188 is suggesting that ivermectin should be taken over more than one day.
actually that's exactly what I was implying that doxy isn't meant and can't stop covid
I was on both ivermectin+doxy so I personally know that a single day/dose of ivermectin is useless for a strong infection, maybe it can work early on in the first few days of getting ill but no way it is enough for weeks into infection or with viral pneumonia
Even the anti-parasite dose is not a single day/dose. This is why every study with a single dose is ridiculous.
ok, now that makes sense. yeah you are right, still this is a "gold standard" RCT with a positive outcome. good news
yeah it's more than nothing but they need to do a full five days or at least a few days
the insight to this is ivermectin only has an 18 hour half life, which means after a day it's almost like it's not in your system anymore, even a "megadose" doesn't solve that problem really
covid has a whole lotta places to hide in the body, it needs to be attacked for more than 24 hours
if remdesivir needs five days, why not test ivermectin also for five days
I figure the USA will finally adopt this despite studies a year after this is no longer needed anymore, maybe with a new CDC and new FDA next year but not holding my breath, hospitals also won't like a $30 drug vs $3000 drug but for "at home" use it could be huge
[-] stereomatch | 9 points | Oct 09 2020 20:59:43
Results:
https://clinicaltrials.gov/ct2/show/results/NCT04523831
Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection
Dr. Reaz Mahmud, Dhaka Medical College
Summary:
This seems to be a double-blind randomized trial (both participants and investigator are unaware who is getting what):
183 patients in ivermectin+doxycycline (plus standard of care) arm - Ivermectin 6mg x 2 tablets = 12mg (given once i.e. total 12mg dose) - Doxycycline 100mg x 2 tablets/day (given for 5 days i.e. total 1000mg dose)
180 patients in placebo arm (standard of care)
Ivermectin+Doxycycline arm had:
older demographic (usually do worse)
more males (usually do worse)
Mortality:
0 deaths in ivermectin+doxycycline arm
3 deaths in placebo arm
(i.e. placebo did worse)
Number of Patients With Early Clinical Improvement (at 7 days):
60.7% patients in ivermectin+doxycycline arm
44.4% patients in placebo arm
p value < 0.03
(i.e. placebo did worse)
Number of Participants With Late Clinical Recovery (requiring more than 14 days to recover):
23% patients in ivermectin+doxycycline arm
37.2% patients in placebo arm
p value < 0.004
(i.e. placebo did worse)
Number of Patients Having Clinical Deterioration (1 month):
8.7% patients in ivermectin+doxycycline arm
17.8% patients in placebo arm
p value < 0.013
(i.e. placebo did worse)
Number of Patients Remain Persistently Positive for RT-PCR of Covid-19 (at day 14):
7.7% patients in ivermectin+doxycycline arm
20.0% patients in placebo arm
p value < 0.001
(i.e. placebo did worse)
Adverse Events:
2 patients had gastrointestinal issues (Erosive esophagitis) in ivermectin+doxycycline arm
0 patients in placebo arm
Minor adverse events:
7 patients had gastrointestinal issues (Non ulcer Dyspepsia) in ivermectin+doxycycline arm
0 patients in placebo arm
Takeaways:
Ivermectin + Doxycycline had better outcomes
Ivermectin dose was only 6mg x 2 tablets = 12mg (given once) - which is at the lower end of dosage for covid-19 (although it is typical for de-worming). Other studies have typically used 2x or 3x this dosage or higher. Also it is not clear if Ivermectin was taken with a fatty meal (which ivermectin spec sheet gives 2.5x bioavailability when taken with fatty meal).
Results are better than what we have seen for Remdesivir etc. - yet are getting scant attention (also lower interest in clinical trials by pharma since being generic drugs there is little financial incentive). Most of the work on Ivermectin is thus coming from outside the U.S./Europe (Bangladesh, Peru, Egypt).
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[-] TrumpLyftAlles | 2 points | Oct 09 2020 21:42:22
Thanks for this great comment.
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